Francine C. Gachupin

Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines From a National Heart, Lung, and Blood Institute Working Group

In January 2009, the National Heart, Lung, and Blood Institute convened a 28-member multidisciplinary Working Group to update the recommendations of a 2004 National Heart, Lung, and Blood Institute Working Group focused on Guidelines to the Return of Genetic Research Results. Changes in the genetic and societal landscape over the intervening 5 years raise multiple questions and challenges. The group noted the complex issues arising from the fact that technological and bioinformatic progress has made it possible to obtain considerable information on individuals that would not have been possible a decade ago. Although unable to reach consensus on a number of issues, the working group produced 5 recommendations. The working group offers 2 recommendations addressing the criteria necessary to determine when genetic results should and may be returned to study participants, respectively. In addition, it suggests that a time limit be established to limit the duration of obligation of investigators to return genetic research results. The group recommends the creation of a central body, or bodies, to provide guidance on when genetic research results are associated with sufficient risk and have established clinical utility to justify their return to study participants. The final recommendation urges investigators to engage the broader community when dealing with identifiable communities to advise them on the return of aggregate and individual research results. Creation of an entity charged to provide guidance to institutional review boards, investigators, research institutions, and research sponsors would provide rigorous review of available data, promote standardization of study policies regarding return of genetic research results, and enable investigators and study participants to clarify and share expectations for the handling of this increasingly valuable information with appropriate respect for the rights and needs of participants.

American Indian and Alaska Native infant and pediatric mortality, United States, 1999-2009

OBJECTIVESnWe described American Indian/Alaska Native (AI/AN) infant and pediatric death rates and leading causes of death.nnnMETHODSnWe adjusted National Vital Statistics System mortality data for AI/AN racial misclassification by linkage with Indian Health Service (IHS) registration records. We determined average annual death rates and leading causes of death for 1999 to 2009 for AI/AN versus White infants and children. We limited the analysis to IHS Contract Health Service Delivery Area counties.nnnRESULTSnThe AI/AN infant death rate was 914 (rate ratio [RR] = 1.61; 95% confidence interval [CI] = 1.55, 1.67). Sudden infant death syndrome, unintentional injuries, and influenza or pneumonia were more common in AI/AN versus White infants. The overall AI/AN pediatric death rates were 69.6 for ages 1 to 4 years (RR = 2.56; 95% CI = 2.38, 2.75), 28.9 for ages 5 to 9 years (RR = 2.12; 95% CI = 1.92, 2.34), 37.3 for ages 10 to 14 years (RR = 2.22; 95% CI = 2.04, 2.40), and 158.4 for ages 15 to 19 years (RR = 2.71; 95% CI = 2.60, 2.82). Unintentional injuries and suicide occurred at higher rates among AI/AN youths versus White youths.nnnCONCLUSIONSnDeath rates for AI/AN infants and children were higher than for Whites, with regional disparities. Several leading causes of death in the AI/AN pediatric population are potentially preventable.

Indigenous Mortality (Revealed): The Invisible Illuminated

Inaccuracies in the identification of Indigenous status and the collection of and access to vital statistics data impede the strategic implementation of evidence-based public health initiatives to reduce avoidable deaths. The impact of colonization and subsequent government initiatives has been commonly observed among the Indigenous peoples of Australia, Canada, New Zealand, and the United States. The quality of Indigenous data that informs mortality statistics are similarly connected to these distal processes, which began with colonization. We discuss the methodological and technical challenges in measuring mortality for Indigenous populations within a historical and political context, and identify strategies for the accurate ascertainment and inclusion of Indigenous people in mortality statistics.

Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants

In January 2009, the National Heart, Lung, and Blood Institute convened a 28-member multidisciplinary Working Group to update the recommendations of a 2004 National Heart, Lung, and Blood Institute Working Group focused on Guidelines to the Return of Genetic Research Results. Changes in the genetic and societal landscape over the intervening 5 years raise multiple questions and challenges. The group noted the complex issues arising from the fact that technological and bioinformatic progress has made it possible to obtain considerable information on individuals that would not have been possible a decade ago. Although unable to reach consensus on a number of issues, the working group produced 5 recommendations. The working group offers 2 recommendations addressing the criteria necessary to determine when genetic results should and may be returned to study participants, respectively. In addition, it suggests that a time limit be established to limit the duration of obligation of investigators to return genetic research results. The group recommends the creation of a central body, or bodies, to provide guidance on when genetic research results are associated with sufficient risk and have established clinical utility to justify their return to study participants. The final recommendation urges investigators to engage the broader community when dealing with identifiable communities to advise them on the return of aggregate and individual research results. Creation of an entity charged to provide guidance to institutional review boards, investigators, research institutions, and research sponsors would provide rigorous review of available data, promote standardization of study policies regarding return of genetic research results, and enable investigators and study participants to clarify and share expectations for the handling of this increasingly valuable information with appropriate respect for the rights and needs of participants.

Cancer patient perceptions about biobanking and preferred timing of consent

Little is known about how cancer patients feel about donating their tissue, especially in a multiethnic population. Structured interviews were conducted with 30 patients recently diagnosed with cancer, referred to the study by six cancer surgeons and oncologists and by other patients in the study. The participants reported a variety of cancers, and the sample reflected the racial distribution of Hawai`i, including Caucasians (23%), Native Hawaiians and Pacific Islanders (27%), Asians (37%), Hispanics (7%), Native Americans (3%), and African Americans (3%). The interview questions and analysis were guided by the Framework Approach, with interview questions based on pre-set aims. Findings suggest that most cancer patients would donate cancer tissue to science, especially if informed that doing so could help researchers find causes of and cures for cancer. Patients varied on when in their cancer journey they would be most receptive to being asked for a donation, however two-thirds thought they would be more receptive if approached after surgery. Only three of the 30 patients said they would want to be re-consented each time their tissue is requested for research. They identified their physician as the preferred messenger regarding tissue donation. No obvious differences were seen by race. Findings confirm those of other researchers who have reported broad support for biobank participation if informed consent and confidentiality could be assured. Given that the physician was seen as the key messenger about biobanking, more education is needed around cancer tissue collection for physicians, as well as for cancer patients.

Anthropometric discriminators of type 2 diabetes among White and Black American adults.

The aim of the present study was to determine the best anthropometric discriminators of type 2 diabetes mellitus (T2DM) among White and Black males and females in a large US sample.

Ethical and Practical Guidelines for Reporting Genetic Research Results To Study Participants: Updated Guidelines from an NHLBI Working Group

In January 2009, the National Heart, Lung, and Blood Institute convened a 28-member multidisciplinary Working Group to update the recommendations of a 2004 National Heart, Lung, and Blood Institute Working Group focused on Guidelines to the Return of Genetic Research Results. Changes in the genetic and societal landscape over the intervening 5 years raise multiple questions and challenges. The group noted the complex issues arising from the fact that technological and bioinformatic progress has made it possible to obtain considerable information on individuals that would not have been possible a decade ago. Although unable to reach consensus on a number of issues, the working group produced 5 recommendations. The working group offers 2 recommendations addressing the criteria necessary to determine when genetic results should and may be returned to study participants, respectively. In addition, it suggests that a time limit be established to limit the duration of obligation of investigators to return genetic research results. The group recommends the creation of a central body, or bodies, to provide guidance on when genetic research results are associated with sufficient risk and have established clinical utility to justify their return to study participants. The final recommendation urges investigators to engage the broader community when dealing with identifiable communities to advise them on the return of aggregate and individual research results. Creation of an entity charged to provide guidance to institutional review boards, investigators, research institutions, and research sponsors would provide rigorous review of available data, promote standardization of study policies regarding return of genetic research results, and enable investigators and study participants to clarify and share expectations for the handling of this increasingly valuable information with appropriate respect for the rights and needs of participants.

A Systematic Review of Barriers and Facilitators to Mammography in American Indian/Alaska Native Women

Introduction: The purpose of this systematic review was to synthesize the current knowledge of factors that enable or impede American Indian and Alaska Native (AI/AN) women from accessing breast cancer screening. Methodology: A systematic search of MEDLINE and CINAHL databases identified relevant research studies published from 2007 to 2017. Results: Consistent with other low-income populations, socioeconomic factors were related to lower rates of screening in AI/AN women. However, some factors, such as reliance on the Indian Health Service, cultural issues, and traditionality were unique to this population. Discussion: AI/AN women appear to face many of the difficulties that other low-income minority women face in accessing preventive care; however, they may face unique challenges and circumstances in accessing care. Efforts to work with tribes in the development of interventions framed by community-based participatory research are needed to tackle the disparities in the AI/AN community.

Addressing Hepatitis C within a Southwest Tribal Community

ObjectivenThe objective was to identify and treat segments of the local population at greatest risk for viral hepatitis C (HCV) infections.nnnDesignnThe tribal-based HCV initiatives included community involvement and outreach and HCV data were mined and analyzed. Medical records were reviewed, and new HCV tribal health policies and procedures were developed.nnnResultsnA total of 251 tribal members (63.7% male) were diagnosed with HCV and had a positive confirmatory test between the years 2009 and 2014. Through community-based outreach efforts, 85 HCV patients were successfully contacted for education, field-testing, referral and follow-up, an increase of more than 300%.nnnConclusionsnThe tribe increased ways to monitor HCV risk factors and communicable disease pathways.

Severe obesity among American Indian tribal youth in the Southwest

Children with obesity are at risk for adult obesity, atherosclerotic cardiovascular disease, type 2 diabetes, stroke, and low self-esteem, and are less likely to participate in physical activity than non-obese youth. The obesity epidemic is due largely to lifestyle behaviours and the built environment that shape life habits in obvious and subtle ways. With early onset of obesity, risks for chronic disease and associated complications have more time to develop. Various studies show that American Indian youth have the highest prevalence of obesity of all racial/ethnic groups in the US. The objective of this study was to quantify the levels of severe obesity by sex among select American Indian tribal youth who attended a summer wellness camp aimed at children at risk for or with type 2 diabetes, between 1995 and 2015.